Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

As discussed in the final guidance, FDA anticipates that the agency and industry will need up to 60 days after the publication of this guidance to operationalize the recommendations discussed; however ...

This committee will establish a system of graphical symbols, charts, matrices, and diagrams that will specify and facilitate implementation of software-based control systems. These documents may ...

STATEMENT ON AUDITING STANDARDS (SAS) no. 96, Audit Documentation, marks the first big change in the requirements auditors must observe when documenting their audit work. It provides general guidance ...

Software documentation can be a hassle—but it doesn't have to be. iX spoke with four experts who share their experiences and offer suggestions for improving the documentation process. Charlotte ...